Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

Bleeding Clinical Trial

Official title:

Reduction Perioperative Bleeding in Laminectomy With Instrumentation or More Than or Equal to 3 Levels Laminectomy: The Comparison Between Placebo, and Double Doses of Tranexamic Acid (15 mg/kg and 15 mg/kg)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643135
• Other study ID #: si248/2012
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2012
• Last updated: December 17, 2013
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).

Description:

78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• has laminectomy with instrumentation or equal or more than 3 levels laminectomy

• age 18-65 years

• ASA 1-3

• elective operation

Exclusion Criteria:

• allergy to tranexamic acid

• anemia (Hb<12 g/dl in female or Hb<13 g/dl in male)

• history of CVT, IHD, PE, strokes

• liver disease

• chronic kidney disease with creatinie>2.0 mg/dl

• receive anticoagulant or coagulopathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Drug:
• tranexamic acid
Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)
• 0.9% NaCl
0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid

Locations

Country	Name	City	State
Thailand	Manee Raksakietisak	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative blood loss	Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage	24 hours	Yes
Secondary	perioperative blood transfusion	When the blood loss more than acceptable and the hematocrit below 30%, the packed red cell will be given.	24 hours	Yes